Levemir PenFill Cartridge 100 Units / mL
Levemir PenFill Cartridge
Insulin detemir
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Diabetes is a condition where the body does not produce enough insulin or uses it efficiently to manage your body’s blood sugar levels.

By injecting insulin, patients are able to manage glycemic control and avoid many serious complications which result from diabetes.

What is the Levemir PenFill Cartridge?

Levemir Penfill (Insulin detemir) 100 units/ml cartridge contains 100 units insulin detemir* (equivalent to 14.2 mg). 1 cartridge contains 3 ml equivalent to 300 units.

What is Levemir?

Levemir® Penfill® cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine® or NovoTwist® needles.

If you are treated with Levemir® Penfill® and another insulin Penfill® cartridge, you should use two insulin delivery systems, one for each type of insulin.

The Levemir PenFill Cartridge contains insulin detemir which is a modern analog used to treat blood glucose levels in children (age 1 year and above), adolescents and adults with diabetes.

Levemir is a long-acting insulin that provides a long and steady glucose-lowering-action that begins 3-4 hours after injection and lasts up to 24 hours.

Levemir can also be used in combination with rapid-acting insulin, other diabetes products such as tablets and/or anti-diabetic products.

Levemir® contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir® is essentially ‘sodium-free’.

USAGE

Before using Levemir

  • Make sure you are using the correct type of insulin by checking the label.
  • Inspect the cartridge including the rubber plunger
  • Do not use if it is damaged. This includes the rubber plunger has been draw above the white label at the bottom of the cartridge. This could indicate an insulin leakage. Return to supplier if you find the cartridge is damaged.
  • To prevent contamination always use a new needle.
  • Do not share the Levemir Penfill or needles as this can lead to spreading infection.
  • Levemir Penfill should only be administered subcutaneously (under the skin).

Always rotate injection sites to avoid changes to the fatty tissue under the skin, such as skin shrinking, thickening or developing lumps on the skin. Notify your doctor if you are currently injecting into affected areas.

Dose and when to take Levemir

Always adjust your insulin dosage and follow regimen as instructed by your doctor or pharmacist.

Levemir can be used in combination with a short- or rapid-acting insulin.

For those with type 2 diabetes, Levemir may be used in combination with other diabetes medications such as tablets or injectable anti-diabetic products.

Your dosage may need to be adjusted if:

  • your doctor switch you over to another brand of insulin
  • your doctor has prescribed another medication to be part of your treatment

How often to inject

Levemir is typically administered once daily. When used as part of a basal-bolus insulin regimen, Levemir is administered twice daily depending on the patients individual needs.

Dosage should be administered at the same time every day.

For patients who require two daily doses, you can administer the second dose in the evening or bedtime in order to optimize blood sugar control.

How and where to inject Levemir

Levemir Penfill is only to be injected under the skin. It should never be injected into a muscle or vein.

The best places for injection include the front of the thigh, upper arm or front of waist (abdomen). Be sure to rotate injection sites and measure blood sugar levels regularly.

Use the injection technique as advised by your doctor or nurse. Also refer to the manual.

Keep the needle in the skin for at least 6 seconds and keep the button pushed until the needle has been fully withdrawn. This will ensure the full delivery of insulin.

Do not refill the cartridge.

Storage

  • Store medication away from children.
  • Do not use this medication after the expiry date indicated on the cartridge or carton.
  • Keep the cartridge in the carton when not in use in order to protect it from direct light.
  • Keep Levemir cartridge away from excessive heat.
  • Before the Levemir Penfill is opened, keep in the refrigerator at 2°C to 8°C.
  • Keep away from cooling element and do not freeze.
  • Levemir Penfills currently in use or as a spare should be kept at room temperature (below 30°C) for up to 6 weeks.
  • Do not discard medication via household waste or wastewater (toilet, sink etc). Speak to your pharmacist about how to properly dispose of medication as these measures will help protect the environment.

SIDE EFFECTS

A side effect is any unwanted response when taking medication in regular doses.

Like all insulin, Levemir may cause side effects however they are not experienced by everyone and often times go away with time.

Hypoglycemia (low blood sugar)

Hypoglycemia is the most common side effect when taking insulin which affects more than 1 in 10 people.

Low blood sugar may be caused by:

  • injecting too much insulin
  • skip a meal or overeat
  • exercise more than usual
  • consume alcohol

Symptoms of hypoglycemia may include:

  • cold sweats
  • headache
  • increased heartbeat
  • illness
  • impaired vision
  • drowsiness
  • nervousness
  • hunger
  • cool pale skin
  • anxiety
  • confusion
  • difficulty concentrating
  • unusual tiredness

Warning signs of hypoglycemia may be gradual and may also include increased thirst, increased urination, nausea or vomiting, feeling drowsy or tired, flushed, dry mouth or dry skin.

If you experience hypoglycemia you will need to consume a sugary snack or beverage or glucose tablet. You should always carry hard candy, jelly beans, sugar packets or glucose tablets around with you just in case. Continue your insulin treatment as usual once your blood sugar levels have stabilized.

Severe hypoglycemia can lead to losing consciousnesses and can lead to brain damage (temporary or permanent). If you become unconscious and cannot consume sugar orally, you will require someone to give you a glucagon injection which is a hormone that will cause your blood sugar to rise. If you do not respond to the glucagon treatment you will need immediate medical attention at a hospital.

Educate family and friends on what to do if you lose consciousness such as turning you over to your side if you pass out and not give you any thing orally such as food or drinks as this might cause you to choke.

Speak to your doctor if you are experiencing consistent low blood sugar levels that result in losing consciousness and requiring glucagon treatment. You may require an adjustment to your insulin treatment (dosage, timing etc).

Hyperglycemia (high blood sugar)

High blood sugar may occur if:

  • you have not injected enough insulin
  • skin an insulin dose
  • ration insulin
  • eat more than usual
  • exercise less than usual
  • get an infection or fever

Warning signs of hyperglycemia include:

  • increased thirst
  • increased urination
  • increased drowsiness or tiredness
  • feeling flushed
  • dry mouth, fruity (acetone) breath
  • feeling ill (nausea or vomiting)
  • loss of appetite

What to do if you experience hyperglycemia:

If you experience any of the signs of hyperglycemia mentioned above, due the following:

  • test your blood sugar levels
  • test your urine for ketones
  • seek medical attention

If not treated, this may lead to a very serious condition called diabetic ketoacidosis which is a build-up of acid in the blood. If untreated this can lead to a diabetic coma and eventually death.

Allergic Reactions

Allergic reactions are rare and usually affect 1 in 10,000 people. Serious allergic reactions to insulin may occur if an individual is allergic to the insulin or one of its ingredients.

Uncommon side effects (occur in less than 1 in 100 people)

Local allergic reactions: such as hives, redness, pain, inflammation, bruising, swelling at the site of injection. These symptoms usually go away after a few weeks. If they do not go away then consult your doctor.

Vision problems: Insulin treatment may disturb your vision, however this symptom is usually temporary.

Swollen joints: Water retention may cause localized swelling around the ankles and joints. Consult your doctor if this does not go away.

Diabetic retinopathy (eye disease related to diabetes): This diabetes can become quite serious if left untreated and can potentially lead to blindness. If you are experiencing diabetic retinopathy and blood sugar levels stabilize quickly, the retinopathy may worsen. Consult your doctor about diabetic retinopathy.

Rare side effects (occurs in less than 1 in 1,000 people)

Painful neuropathy (pain due to nerve damage): If your blood sugar levels improve quickly, you may experience nerve related pain. This side effect is usually transient and can be quite painful.

Report side effects

If you experience any side effects, inform your doctor or pharmacist. This also includes any side effects that have not been listed above.

WARNINGS & PRECAUTIONS

Do not use Levemir if:

  • You are allergic to insulin detemir or any of the ingredients it contains.
  • If you are experiencing hypoglycemia (low blood sugar).
  • Used with insulin pumps.
  • If the device is damaged, crushed or dropped.
  • It has been previously frozen.
  • It does not appear colorless or clear.

Your approval to use insulin or dosage requirements may be affected by the following:

  • If you have trouble with your liver or kidneys or your thyroid, pituitary or adrenal glands.
  • If you exercise more than regular or have made drastic dietary changes which can affect your blood glucose levels.
  • If you are travelling abroad to a different time zone. Your insulin schedule may change as a result.
  • If you are experiencing illness. If this happens, do not stop taking your insulin and consult your doctor.
  • If you experience skin changes at injection site.
  • If you have a very low albumin you will need to monitor your blood sugar levels.

Inform your doctor or pharmacist if you are currently taking, or have recently taken any of the medications mentioned below. These medications may affect blood glucose levels and may require an adjustment to your insulin treatment.

Hypoglycemia (low blood sugar) may occur if you take:

  • Anabolic steroids (such as testosterone)
  • Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or Beta-blockers (used to treat high blood pressure)
  • Monoamine oxidase inhibitors (MAOI) (used to treat depression)
  • Salicylates (used to relieve pain and lower fever)
  • Sulphonamides (used to treat infections)
  • Other diabetes medications

Hyperglycemia (high blood sugar) may occur if you take:

  • Beta-blockers
  • Danazol
  • Glucocorticoids
  • Growth hormone
  • Octreotide and lanreotide
  • Oral contraceptives
  • Pioglitazone
  • Thiazides
  • Thyroid hormones
  • Sympathomimetics

Drinking Alcohol

Alcohol may affect blood sugar levels, causing them to rise or fall. It’s recommended to be careful when drinking alcohol and monitor blood sugar levels.

Pregnancy and Breast feeding

Consult your doctor if you are pregnant or planning on pregnancy as this may affect your insulin dosage. Expecting mothers will need to monitor their blood sugar levels to avoid hypoglycemia and avoid any complications.

Breast feeding mothers may require an adjustment to their dosage. Speak to your doctor or pharmacist if you are taking Levemir while breast feeding or pregnant.

Driving or operating heavy machinery

Discuss with your doctor whether it is safe for you to drive or operate heavy machinery while taking Levemir. Let them know if you:

  • experience frequent hypoglycemia
  • find it hard to recognize hypoglycemia
  • if your blood sugar levels are too high or low as they may affect concentration and could lead to endangering yourself and/or others

Some patients with type 2 diabetes and heart disease or previous stroke that were treated with insulin and pioglitazone experienced the development of heart failure.

Consult your doctor immediately if you experience signs of heart failure that may include rapid weight gain, shortness of breath or localized swellin (edema).

Let your doctor know if you have taken any of the medications listed above and if you are taking any other prescription medication, over-the-counter medications, vitamins or herbal supplements.

Inform your doctor if you have any significant health complications including:

  • if you smoke
  • are pregnant or breastfeeding
  • have allergies to any medications
  • if you are currently taking any other prescription medication, OTC drugs, vitamins or supplements.
INSTRUCTIONS FOR USE

FREQUENTLY ASKED QUESTIONS

This product is to be injected underneath the skin (subcutaneously).

  • clean the cartridge tip with an alcohol and attach needle
  • select required dose
  • clean the injection site area with an alcohol swab
  • pinch the skin of the injection site
  • inject insulin into the fold

Levemir can be used by children (1 year and above) and adolescents. There is currently not enough information on the efficacy of using Levemir on children under the age of 1.

Do not stop your insulin treatment without consulting your doctor first. If you stop taking your insulin, this can result in severe hyperglycemia and/or ketoacidosis.

The active substance in Levemir is insulin detemir. Each ml contains 100 units of insulin detemir. Each Levemir cartridge contains 300 units of insulin detemir in 3ml solution for injection. 1 unit of insulin detemir corresponds to 1 international unit (IU) of human insulin.

Other ingredients in include: phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, glycerol, sodium hydroxide and water for injection.

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